AQUABPLUS, B2, HF 1500 KIT
Report
- Report Number
- 3010850471-2025-00007
- Event Type
- Malfunction
- Date Received
- January 30, 2025
- Date of Event
- January 20, 2025
- Report Date
- February 12, 2025
- Manufacturer
- VIVONIC GMBH
- Product Code
- FIP
- PMA / PMN Number
- K133829
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE REPORTED THERMAL DAMAGE WAS CONFIRMED BY THE MANUFACTURER WITH THE PROVIDED PHOTOGRAPH AND INTAKE INFORMATION. THE MOST LIKELY CAUSE FOR THE FAILURE PATTERN IS A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE AND PUMP CURRENT INCREASED WHICH LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS RESULTED IN OVERHEATED AND DISCOLORED CABLE LUGS AT THE MOTOR PROTECTION SWITCH. THE MOTOR PROTECTION SWITCH WAS LOADED UNBALANCED AND TRIPPED, INTERRUPTING DEVICE OPERATION. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. AN IMPROVEMENT TO THE WIRING DESIGN WAS CREATED AND RELEASED. IT IS RECOMMENDED TO REPLACE THE WIRING AND MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO PREVENT ADDITIONAL FAILURES.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED STATED THERE WAS THERMAL DAMAGE TO ONE CONNECTOR OF THE POWER CABLE CONNECTED TO THE MOTOR PROTECTION SWITCH (MPS). THE ISSUE WAS REPORTED DURING MACHINE REPAIR FOR A SEPARATE ISSUE. THE BIOMED INITIALLY CONTACTED FRESENIUS AFTER RECEIVING ERROR W-04-50-02 T1 TEST, FL-F SENSOR DEFECTIVE DURING RINSE MODE FOR WHICH THE BIOMED WAS ADVISED TO REPLACE THE FL-F SENSOR BLOCK AND NOZZLE. UPON FOLLOW-UP THE BIOMED CONFIRMED THE REPORTED THERMAL DAMAGE. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. A REPLACEMENT POWER CABLE (PART NUMBER F50005232) WAS ORDERED. THE MACHINE REMAINS IN SERVICE PENDING REPAIR AND THE REPLACEMENT OF THE POWER CABLE. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.
THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED STATED THERE WAS THERMAL DAMAGE TO ONE CONNECTOR OF THE POWER CABLE CONNECTED TO THE MOTOR PROTECTION SWITCH (MPS). THE ISSUE WAS REPORTED DURING MACHINE REPAIR FOR A SEPARATE ISSUE. THE BIOMED INITIALLY CONTACTED FRESENIUS AFTER RECEIVING ERROR W-04-50-02 T1 TEST, FL-F SENSOR DEFECTIVE DURING RINSE MODE FOR WHICH THE BIOMED WAS ADVISED TO REPLACE THE FL-F SENSOR BLOCK AND NOZZLE. UPON FOLLOW-UP THE BIOMED CONFIRMED THE REPORTED THERMAL DAMAGE. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. A REPLACEMENT POWER CABLE (PART NUMBER F50005232) WAS ORDERED. THE MACHINE REMAINS IN SERVICE PENDING REPAIR AND THE REPLACEMENT OF THE POWER CABLE. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 589440 | AQUABPLUS, B2, HF 1500 KIT | SUBSYSTEM, WATER PURIFICATION | FIP | VIVONIC GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |